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CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03785405
Collaborator
(none)
240
Enrollment
80
Locations
1
Arm
56
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
N/A
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319
Actual Study Start Date :
May 2, 2019
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: sacubitril/valsartan

single arm, open label sacubitril/valsartan

Drug: sacubitril/valsartan
Target dose 3.1 mg/kg bid Formulations: Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)
Other Names:
  • LCZ696

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [to end of study, up to 3 years]

      Safety. Assessments include: Adverse Events (AEs)

    2. Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability [to end of study, up to 3 years]

      Safety. Assessments include: Serious Adverse Events (SAEs)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed informed consent

    • On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue

    Exclusion Criteria:

    • Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2

    • Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour washout before baseline visit)

    • History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan

    • Renal vascular hypertension (including renal artery stenosis)

    • Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder

    • History of angioedema

    • Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures

    • Any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study

    • Other protocol defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Loma Linda California United States 92354
    2 Novartis Investigative Site Los Angeles California United States 90095
    3 Novartis Investigative Site Palo Alto California United States 94304
    4 Novartis Investigative Site Hollywood Florida United States 33021
    5 Novartis Investigative Site Saint Petersburg Florida United States 33701
    6 Novartis Investigative Site Atlanta Georgia United States 30322
    7 Novartis Investigative Site Indianapolis Indiana United States 46202
    8 Novartis Investigative Site Boston Massachusetts United States 02115
    9 Novartis Investigative Site Ann Arbor Michigan United States 48109-5238
    10 Novartis Investigative Site Minneapolis Minnesota United States 55455
    11 Novartis Investigative Site Rochester Minnesota United States 55905
    12 Novartis Investigative Site Saint Louis Missouri United States 63110
    13 Novartis Investigative Site New York New York United States 10032
    14 Novartis Investigative Site Charlotte North Carolina United States 28203
    15 Novartis Investigative Site Philadelphia Pennsylvania United States 19104
    16 Novartis Investigative Site Pittsburgh Pennsylvania United States 15224
    17 Novartis Investigative Site Ciudad de Salta Provincia De Salta Argentina A4406BPF
    18 Novartis Investigative Site Innsbruck Austria 6020
    19 Novartis Investigative Site Sofia Bulgaria 1309
    20 Novartis Investigative Site Edmonton Alberta Canada T6G 1C9
    21 Novartis Investigative Site Toronto Ontario Canada M5G 1X8
    22 Novartis Investigative Site Zagreb Croatia 10000
    23 Novartis Investigative Site Praha 5 Czechia 150 06
    24 Novartis Investigative Site Helsinki Finland 00290
    25 Novartis Investigative Site Paris France 75015
    26 Novartis Investigative Site Berlin Germany 13353
    27 Novartis Investigative Site Erlangen Germany 91054
    28 Novartis Investigative Site Freiburg Germany 79106
    29 Novartis Investigative Site Heidelberg Germany 69120
    30 Novartis Investigative Site Stuttgart Germany 70174
    31 Novartis Investigative Site Budapest Hungary H 1096
    32 Novartis Investigative Site New Delhi Delhi India 110076
    33 Novartis Investigative Site Ahmedabad Gujarat India 380 060
    34 Novartis Investigative Site Kochi Kerala India 682041
    35 Novartis Investigative Site New Delhi India 110029
    36 Novartis Investigative Site Be'er-Sheva Israel 84101
    37 Novartis Investigative Site Bergamo BG Italy 24127
    38 Novartis Investigative Site Bologna BO Italy 40138
    39 Novartis Investigative Site Firenze FI Italy 50132
    40 Novartis Investigative Site Milano MI Italy 20162
    41 Novartis Investigative Site Roma RM Italy 00165
    42 Novartis Investigative Site Torino TO Italy 10126
    43 Novartis Investigative Site Napoli Italy 80131
    44 Novartis Investigative Site Obu Aichi Japan 474 8710
    45 Novartis Investigative Site Sapporo city Hokkaido Japan 060 8648
    46 Novartis Investigative Site Omura Nagasaki Japan 856-8562
    47 Novartis Investigative Site Bunkyo ku Tokyo Japan 113 8655
    48 Novartis Investigative Site Setagaya-ku Tokyo Japan 157-8535
    49 Novartis Investigative Site Shinjuku ku Tokyo Japan 162 8666
    50 Novartis Investigative Site Toyama-city Toyama Japan 930-0194
    51 Novartis Investigative Site Saitama Japan 330 8777
    52 Novartis Investigative Site Yangsan Si Gyeongsangnam Do Korea, Republic of 50612
    53 Novartis Investigative Site Seoul Korea, Republic of 03080
    54 Novartis Investigative Site Seoul Korea, Republic of 03722
    55 Novartis Investigative Site Seoul Korea, Republic of 06351
    56 Novartis Investigative Site Ashrafieh Lebanon 166830
    57 Novartis Investigative Site Beirut Lebanon
    58 Novartis Investigative Site Warszawa Poland 04 730
    59 Novartis Investigative Site Wroclaw Poland 51-124
    60 Novartis Investigative Site Carnaxide Lisboa Portugal 2799 523
    61 Novartis Investigative Site Coimbra Portugal 3000 075
    62 Novartis Investigative Site Lisboa Portugal 1169 024
    63 Novartis Investigative Site Moscow Russian Federation 125412
    64 Novartis Investigative Site Saint Petersburg Russian Federation 197341
    65 Novartis Investigative Site Singapore Singapore 119260
    66 Novartis Investigative Site Singapore Singapore 229899
    67 Novartis Investigative Site Soweto Gauteng South Africa 2013
    68 Novartis Investigative Site Cordoba Andalucia Spain 14004
    69 Novartis Investigative Site Barcelona Cataluna Spain 08950
    70 Novartis Investigative Site Barcelona Catalunya Spain 08035
    71 Novartis Investigative Site Madrid Spain 28009
    72 Novartis Investigative Site Madrid Spain 28046
    73 Novartis Investigative Site Lausanne Switzerland 1011
    74 Novartis Investigative Site Tainan Taiwan 70403
    75 Novartis Investigative Site Taipei Taiwan 10041
    76 Novartis Investigative Site Bangkoknoi Bangkok Thailand 10700
    77 Novartis Investigative Site Bangkok Thailand 10400
    78 Novartis Investigative Site Ankara Turkey 06490
    79 Novartis Investigative Site Izmir Turkey 35040
    80 Novartis Investigative Site Konak-Izmir Turkey 35210

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03785405
    Other Study ID Numbers:
    • CLCZ696B2319E1
    First Posted:
    Dec 24, 2018
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    heart failure
    pediatric
    LCZ696
    sacubitril/valsartan
    open-label study
    angiotensin receptor neprilysin inhibitor
    Additional relevant MeSH terms:
    Heart Failure
    Valsartan
    Sacubitril and valsartan sodium hydrate drug combination

    Study Results

    No Results Posted as of Aug 24, 2022